Implantable Medical Devices and EHR Systems

Shepherdstown 26 May 2007Implantable systems will revolutionize health care in the coming decades. This article examines relevant information about the development of implantable solutions in health care to date, draws a relationship between selected implantable devices and electronic health record (EHR) systems, highlights major issues including ethical concerns, and offers a set of recommendations to health care organizations on next steps to take. In the coming decades, cheaper and high-performance implantable health care solutions based on emerging nanotechnologies will dramatically change the daily clinical practices of many health care providers and the lives of the patients they treat.

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General Overview

The insertion and management of artificial devices implanted within the human body will become increasingly common for maintaining and improving health. "Implantables" have already evolved from artificial hips and knees to assistive devices that have built-in electronics such as artificial pacemakers or cochlear implants. Implantable eCare systems are the next wave: integrated, internal implants that communicate with external monitoring devices outside of the body and through the Internet.

Around the globe, the market for electronically driven implantable devices is set to expand significantly. Medical implants comprise a $23 billion industry in the United States and will reach $33.8 billion by 2009. U.S. demand for implantable devices will grow about 10 percent annually through 2009 based on an expanding prevalence of chronic disorders coupled with new product introductions.

Implantable eCare involves the creation of nanotechnology health care devices that will be constructed, inserted, and applied within the human body. The National Institute of Health (NIH) Roadmap of Nanomedicine initiatives anticipates that in the next 20 to 30 years, nano-sized implantable solutions will be developed that can search out and destroy cancer cells that would otherwise cause a tumor to develop in the body. Nano-sized implantable biological devices will be used to repair tissue or replace particular body parts. The following are a few selected examples of implantable technologies already being used in the health care arena:

  • Implantable Patient ID/Information Microchips
  • Implantable Cardioverter-Defibrillators & Pacemakers
  • Implantable Visual Sensory Aids & Hearing Devices
  • Implantable Stimulators - Brain/Nerves/Bladder/Diaphram ...
  • Implantable Drug Administration & Pain Control Devices
  • Implantable Sensors and/or Active Monitoring Devices

Initially these implantable devices were passive in nature, simply monitoring a particular condition. Over time these devices became active in nature, performing a particular action based on the monitoring capabilities of the implantable devices. We are now moving into the realm of interactive implantable systems. As the capabilities of these implantable nanotechnology medical devices are enhanced to receive, store, transmit, and act on information, one can only imagine how these will be used in the future to treat illnesses and improve our overall health.

Definitions

A medical device is defined as "implantable" if it is either partly or totally introduced, surgically or medically, into the human body and intended to remain after the procedure.

A human microchip implant is an integrated circuit device or RFID tag encased in silicate glass and implanted into a human's body. Such implants can be used for information storage, including personal identification, medical history, medications, allergies, and contact information.

Nanotechnology & Implantable Healthcare Solutions

It is widely accepted that R&D in nanotechnology requires an inter-disciplinary collaborative approach. Early nano-sized implantable medical solutions include: focused pharmaceutical delivery systems; "laboratories on a chip" that perform multiple medical tests invitro or invivo; health related imaging nanodevices; nanosurgical tools; nanomedibots; and other nanotechnology implantable devices. Within several years, advanced drug delivery systems are expected to become commercially available, including implantable devices that automatically administer drugs, biosensors, medical diagnostic tools, cancer tagging mechanisms, and implantable real time diagnostic devices. Based on a review of the literature, brief descriptions of some of these existing implantable solutions follow.

Implantable Personal ID/Information Microchips

In 2004, VeriChip received preliminary approval from the U.S. Food and Drug Administration (FDA) to market its RFID microchip device in the United States within specified guidelines. The tiny electronic capsule transmits a unique code to a scanner that allows doctors to confirm a patient's identity and obtain detailed medical record information from an associated secure database. The goal is to improve care and avoid errors by ensuring that doctors know whom they are treating and the patient's personal health details. See www.washingtonpost.com/wp-dyn/articles/A29954-2004Oct13.html

Since the FDA clearance of VeriChip for medical applications, five hospitals have agreed to adopt the VeriChip system in their emergency departments. However, as of the end of 2006, only 222 medical patients in total had opted to get the RFID chips from VeriChip implanted, according to documents filed with the Securities and Exchange Commission. Sales are expected to increase over time as new applications for VeriChip emerge.

In August 2006, VeriChip made its first sale of a fully integrated system for infant protection, wander prevention of geriatric or mental health patients, and other selected asset protection. Inter-connection to the Australian based Austco nurse call system will enable staff to receive notification remotely of all events, whether from the VeriChip systems or the nurse call system, via any text-enabled device, including PDAs and wireless phones. See www.hoise.com/vmw/06/articles/vmw/LV-VM-09-06-22.html

Implantable Biosensors & Monitoring Devices

Silicon chips and microelectromechanical systems (MEMS) that can be implanted in the human body may ultimately allow semiconductor devices to be interfaced with living tissues. This will open the door to implantable biosensors that can test indicators of disease or symptoms and then regulate the release of a drug to help treat the disease. For instance, an implanted glucose sensor could be coupled to an insulin release system and so help diabetes sufferers control their blood sugar without pin-prick tests or the need to inject insulin. See www.reactivereports.com/41/41_3.html

While the problems of long-term stability and biocompatibility are being addressed, several promising prototypes are starting to emerge for managing patients with acute diabetes, for treatment of epilepsy and other debilitating neurological disorders, and for the monitoring of patients with chronic cardiac diseases (see http://bsn.media.mit.edu/). Examples include:

Implantable Glucose Sensors - Last year, Zyvex Corporation, a molecular nanotechnology company specializing in micro-electro-mechanical systems (MEMS) selected Diabetech LP as its medical device development and commercialization partner for their wireless sensor implant targeting real-time blood glucose levels in the body. Their innovative handheld device for patients not only displays the glucose levels from the implant to the patient but also automatically relays that information in real-time to GlucoDYNAMIX, Diabetech's clinical management system. This is an example of an active implantable device. See www.hoise.com/vmw/06/articles/vmw/LV-VM-03-06-37.html

Similarly, Digital Angel was awarded a patent in October 2006 for their embedded biosensor system. The system works by implanting a glucose-sensing RFID microchip into the patient. The chip can more accurately measure glucose levels and actively report it back to a digital scanner. See http://jonesreport.com/articles/261006_rfid_award.html

Implantable EKG Monitors - According to an article in Virtual Medical Worlds, the Academy of Finland has funded a wireless research project to develop miniscule subcutaneous sensors, which can be used to actively monitor the function of the heart or prosthetic joints even over long periods of time. "For example, a subcutaneous EKG monitor will be able to detect cardiac arrhythmia, and the data for this can then be transmitted wirelessly to the physician's mobile phone or PC", according to Professor Lekkala. See www.hoise.com/vmw/05/articles/vmw/LV-VM-12-05-30.html

Chronic Disease Monitoring - Guidant Corporation has specialized in the treatment of cardiac and vascular disease and has made an equity investment in CardioMEMS Inc., according to an article previously published in Virtual Medical Worlds. CardioMEMS develops innovative devices based on micro-electromechanical systems (MEMS) technology to enable physicians to remotely monitor the progression of chronic diseases such as heart failure. See www.hoise.com/vmw/03/articles/vmw/LV-VM-12-03-24.html

In 2006, the University of Texas received a grant to fund research and development of an implantable intravascular biosensor that will monitor health and disease progression. The nano-sized pressure sensor will monitor pressure within the cardiovascular system and blood flow, while transmitting the information to a wristwatch-like data collection device. The external device then transmits the data to a central remote monitoring station where it can be viewed in real time by health care providers. See www.hoise.com/vmw/06/articles/vmw/LV-VM-10-06-7.html

Implantable Cardioverter Defibrillators & Pacemakers

Implantable Cardioverter-Defibrillators - The implantable cardioverter-defibrillator (ICD) has revolutionized the treatment of patients at risk for sudden cardiac death due to ventricular tachyarrhythmias. Initially introduced in humans in 1980 and approved by the Food and Drug Administration (FDA) in 1985, the ICD has evolved from a treatment of last resort to a first-line treatment and prophylactic therapy for patients at risk for ventricular tachycardia (VT) or ventricular fibrillation (VF). This according to an article by Daniel Beyebach, MD, in eMedicne, September 2006. See www.emedicine.com/med/topic3386.htm

According to an earlier article published in Virtual Medical Worlds, the Medtronic CareLink Monitor is a small, easy-to-use device which allows patients to collect information simply by holding a small "antenna" over their implanted cardiac device. The monitor automatically downloads the data and sends it through a standard home telephone connection directly to the secure Medtronic CareLink Network. Clinicians access their patients' data by logging onto the clinician web site from any Internet-connected computer in their office or home, or via laptop while traveling. The Medtronic CareLink Network is the industry's first Internet-based service that connects cardiac device patients and physicians for "virtual office visits". See www.hoise.com/vmw/02/articles/vmw/LV-VM-04-02-27.html

The Merlin Patient Care System, a portable system that programs St. Jude Medical's implantable cardioverter defibrillators (ICDs) and pacemakers. This interactive system supports current and previous generation devices. It is a portable computer with an LCD touch screen that enables clinicians to retrieve and analyze patient information during routine follow-up visits and quickly and easily make programming changes to the implanted devices. www.hoise.com/vmw/06/articles/vmw/LV-VM-07-06-8.html

Implantable Drug Administration

Nanotechnology is opening up new opportunities in implantable drug delivery systems. The job of this type of implantable device is to deliver small amounts of drugs on a daily basis such that the patient no longer needs to get an injection every day or week. Implantable drug delivery devices tend to give a more constant drug level in the blood than injections. By the use of active monitoring capabilities of the device, the drug level in the blood can be adapted to variations in physical activity, changes in temperature, and other variables. In chemotherapy and similar treatments, the device can be implanted at the place where the drug is needed such that in the rest of the body the concentration of the drug is much lower. Implantable drug delivery devices are also useful for hormonal treatments and many other treatments where small drug dosages are needed.

"Smart" implantable insulin pumps are designed to provide relief for people with Type I diabetes. These are active implantable drug delivery devices that build upon and go beyond the capabilities provided by the more passive glucose biosensors mentioned earlier in this article. See http://biology.about.com/library/weekly/aa061099.htm

According to a recent article in The Business Review, St. Peter's Hospital in Albany, N.Y., recently replaced every one of its 540 intravenous pumps with "smart pumps". The B-Braun Outlook Safety Infusion Pump is designed to reduce the risks of human error associated with medication dosing. Alfonzo DiBlasio, Director of Clinical Technology Management at St. Peter's said, "These smart pumps have a drug library and the ability to create limits". "If a nurse enters a dosage above or below the set limit, the machine will sound an alarm and will tell the nurse what the error is and how to fix it." The new technology also includes wireless transmitters that send information from every pump to a central database in real time, for quality assurance. See http://www.bizjournals.com/albany/stories/2007/03/19/daily30.html?b=1174276800^1436322

The market for implantable drug delivery systems is growing and forecast to reach $9 billion by 2010, according to a new report published in 2007 by Kalorama Information. One can already begin to envision more interactive drug delivery devices linked to electronic health record (EHR) systems of the future.

Implantable Vision & Hearing Aids

There are a number of implantable sensory aids. At this point in time most of these are passive implants and do not have any interactive system capabilities. They simply perform the function for which they were designed, but do not yet collect data for subsequent transmission and interaction with external information systems. For example:

Implantable Miniature Telescope - This visual prosthetic device is designed to improve vision and quality of life for individuals with moderate to profound vision loss caused by dysfunction of the macula. See www.visioncareinc.net/technology.html

Implantable contact lenses (ICLs) correct vision in much the same way that external contact lenses do, except ICLs are placed inside the eye where they permanently improve vision. See www.docshop.com/education/vision/refractive/icl/

Implantable hearing aid systems consist of a tiny magnet placed inside the middle ear and an external sound processor. The implantable magnet should last forever and not require replacement, however, the external portion which fits in the ear canal may need to be changed every five years or so. See http://healthlink.mcw.edu/article/1014763100.html

Implantable Stimulators - Brain/Nerves/Limbs

According to a recent article, scientists at the U.S. Department of Veterans Affairs (VA) hope to create "biohybrid" limbs that will use regenerated tissue, lengthened bone, titanium prosthetics and implantable sensors that allow amputees to use nerves and brain signals to move arms or legs. The aim is to give amputees, particularly war veterans, better mobility and control of their limbs and to reduce the discomfort and infections common with current prosthetics. See www.hoise.com/vmw/05/articles/vmw/LV-VM-01-05-15.html

In recent years, a number of promising clinical prototypes of implantable and wearable monitoring devices have started to emerge. Whilst the problems such as long-term stability and biocompatibility are being actively pursued, their potential clinical value is increasingly being recognized. For epilepsy and other debilitating neurological disorders, there are already on the market implantable, multi-programmable brain stimulators that save the patient from surgical operations. Similar applications have also been identified in cardiology for the identification and prediction of life threatening episodes. See www.healthcare.pervasive.dk/ubicomp2004/papers/final_papers/laerhoven.pdf

In 2006, an article in Virtual Medical Worlds presented an update on Cyberkinetics' ongoing BrainGate Neural Interface System pilot clinical trials. Recent Cyberkinetics presentations have included new data from the surgical, neurological and scientific efforts that have led to the use of the BrainGate System by those with quadriplegia to control computer interfaces using thought. Dr. Friehs discussed the future of Cyberkinetics' neural sensing technology, including the development of a long-term, wireless system and the potential for using BrainGate-based sensor technology to both sense and respond in a number of therapeutic applications, such as seizure prediction and tremor control. See www.hoise.com/vmw/06/articles/vmw/LV-VM-07-06-38.html

Implantables: Other Technology Advances

Examples of a number of recent technological advances that will further advance the use and capabilities of implantable medical systems should also be mentioned. For example:

Vancouver's EaglePicher Medical Power has recently announced plans to unveil the "industry's smallest implantable-grade medical battery". It can purportedly provide power for "more than 15 years". See www.engadget.com/2007/03/18/eaglepicher-claims-worlds-smallest-implantable-battery/

A company called Implint is working on implantable devices that provide the person in whom it is implanted with some degree of Internet connectivity. There are some implantable medical devices that are already capable of limited connectivity with the Internet - uploading or downloading specific types of data. See www.implint.com/

Zarlink Semiconductor has introduced the world's first transceiver chip designed exclusively for wireless communication systems that link implanted medical devices and base stations. Advances in ultra low-power radio expertise and global adoption of the MICS 402-405 MHz frequency band for implanted communications opens the door for advanced telemedicine applications that extend patient health monitoring beyond the traditional clinical setting. Physicians can use MICS technology to remotely monitor patient health without requiring regular hospital visits. See www.hoise.com/vmw/05/articles/vmw/LV-VM-07-05-10.html

For some time the U.S. military medical services have focused research on non-invasive physiological monitoring sensors as a means of obtaining data for remote triage of combat casualties and for soldier health and performance monitoring. The Telemedicine and Advanced Technology Research Center (TATRC), within the U.S. Department of Defense (DoD), has also been funding work on invasive/internal physiological sensors. There are numerous potential battlefield applications of these Implantable devices. See http://www.asc2006.com/posters/KP-39.pdf

By converting mechanical energy from body movement, muscle stretching or water flow into electricity, nanogenerators could make possible a breakthrough class of self-powered implantable medical devices and bio-sensors. For example, Biophan Technologies' subsidiary TE-Bio has developed a biothermal power source that converts body heat into electricity to power implantable medical devices. NASA has engaged with TE-Bio for advancing high-density, nanoengineered thermoelectric materials for use with implantable medical devices. The life of many implantable devices may now be extended by deriving energy from the heat produced by the body. See http://www.nanotechwire.com/news.asp?nid=1054

Recommended reading - A relatively new book highlighting the results of recent research projects in this field of eHealth was published by IOS Press entitled "Wearable eHealth Systems for personalized health management, state of the art future challenges". It includes sections on smart wearable implantable disease management systems and is worth reading. See www.hoise.com/vmw/04/articles/vmw/LV-VM-12-04-17.html

Implantable Technologies & Electronic Health Record (EHR) Systems

The primary focus of most health care provider organizations today is on the acquisition and continued deployment of EHRs within their own systems. Over time these health care providers expect the EHR vendors to deliver connectivity and interoperability within a region, across the nation, and even around the world. As of 2006, it appears that less than 20 percent of health care provider organizations may have acquired and implemented a comprehensive electronic health record (EHR) system with physician order entry capabilities. However, a 2006 HIMSS survey indicated that more than 80 percent of hospital and health systems in the United States plan on installing clinical information systems over the next five years.

While nanotechnology has begun to play a significant role in medicine, making computing and communications systems microscopic in size and more conducive to on-body usage as noted above, nanotechnology solutions in medicine are still in the early stages of development and deployment. Integration of nanomedicine and implantable technology solutions with EHR and personal health record (PHR) systems will not begin to truly emerge to any great degree until the end of the next decade.

The authors project that by the year 2020 implantable medical sensors feeding data to EHR and PHR systems will be more widely utilized. Advanced drug delivery systems are expected to become commercially available, including implantable nanomedicine devices that automatically sense drug levels and administer medication. Implantable medical diagnostic tools, such as cancer tagging mechanisms, and "lab-on-a-chip" real time diagnostics for physicians will become available that will be interfaced to EHR and PHR systems. Implantable nanoimaging devices will be used to record clinical images that will then be stored in a patient's personal electronic health record.

We are in the process of moving from a limited range of passive implantable medical bio-sensors and monitoring devices to active implantable cardioverter-defibrillators and drug administration devices. In the coming decade these devices will be more interactive in nature, having the capability to securely transmit information to EHR systems so clinicians can view it and issue directions to the implantable device. As we stated at the outset, implantable systems will revolutionize health care in the coming decades. However, we still have a long way to go.

Selected Key Issues - Ethics, Privacy & Security

When the VeriChip company first began touting their implantable RFID technology nearly four years ago, it was criticized by civil libertarians, who saw the chips as a gateway to privacy erosion, and by religious consumers some of whom said that implantable chips were the "mark of the beast". In an SEC filing, the company stated that many doctors have been reluctant to discuss the procedure with clients. Bad publicity surrounding the subject to date may have been a factor.

At the 20th World Conference of Philosophy (WCP), ethical issues raised included safety, informed consent, issues of manufacturing and scientific responsibility, anxieties about the psychological impacts of enhancing human nature, and worries about possible usage in children. Implantable chips bear great promise but work on privacy standards is still needed. See www.bu.edu/wcp/Papers/Bioe/BioeMcGe.htm

If implantable microchips are completely unencrypted, they would be extremely vulnerable to hacker attacks and interception by third-party scanners. By scanning secretly, someone could steal all of the information on a chip and could clone the signal, possibly leading to criminal misuse of medical files and insurance information. Further, a patient's prescription profile or list of known allergies could be altered maliciously, causing injury or death. The patient's medical insurance information could potentially be copied for another unrelated person to use. Security of implantable systems has not yet been adequately addressed.

Recommended Next Steps

Implantable medical technologies, will revolutionize health care in the coming decades and will change the daily business practices of health care organizations and enhance how they provide patient care. The following set of recommendations is presented on possible next steps for large health care provider organizations to take:
  • Health care organizations should continually monitor innovations, clinical trials and developments related to this area and other emerging health IT solutions.
  • Consider establishing a multi-disciplinary Implantable Technology working group.
  • Monitor and obtain lessons learned from existing implantable health care technology projects around the world.
  • Consider becoming involved in selected implantable research and development (R&D) efforts that relate to the delivery of patient-centric health care and health information systems.
  • Identify implantable medical technology pilot projects involving product development and implementation that may specifically benefit your patients in the future (e.g., biosensors, drug delivery, gene therapy, diagnostics).
  • Conduct Cost-Benefit Analysis and Return On Investment (ROI) studies for these type of initiatives before making any major commitment by your organization.
  • Investigate changes in clinical practices and business processes that your organization may need to make in anticipation of implementing implantable technology applications/devices in the future.
  • Recognize that this technology will not begin to mature for at least 10 more years.

One final note - At the 20th World Congress of Philosophy, it was stated that computer scientists predict that within the next twenty years neural interfaces will be designed that will not only increase the dynamic range of senses, but will also enhance memory and enable "cyberthink" - invisible communication with others. This technology will facilitate consistent and constant access to information when and where it is needed. "Think about it."

The authors delve deeper into this area and further elaborate on other related emerging technologies in health care in their recent book entitled "Medical Informatics 2020", published in January 2007 by Jones & Bartlett. See http://www.jbpub.com/catalog/0763739251. Also, visit the Virtual Center for Collaboration, Open Solutions, and Innovation (COSI) in Healthcare at www.shepherd.edu/surc/cosi

Authors:

Peter J. Groen is on the faculty of the Computer & Information Science Department at Shepherd University in West Virginia and is one of the founders of the Shepherd University Research Corporation - see www.shepherd.edu/surc

Marc Wine is a coordinator for Intergovermental Health IT within the Office of Intergovernmental Solutions at the U.S. General Services Administration (GSA). He also is a guest lecturer on Medical Informatics at the George Washington University in Washington, D.C.

Douglas Goldstein is an "eFuturist", author, guest speaker, and CEO of Medical Alliances, Inc., leading online communities and health care companies implementing Web 2.0 solutions. See www.medicalalliance.com.


Peter J. Groen, Marc Wine and Douglas Goldstein

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